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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000044443
Receipt No. R000050774
Scientific Title Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Date of disclosure of the study information 2021/06/05
Last modified on 2021/06/05

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Basic information
Public title Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Acronym Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Scientific Title Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Scientific Title:Acronym Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Region
Japan

Condition
Condition Colorectal liver metastases (CRLM)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate risk factors of SSI in patients who underwent liver resection for CRLM and to establish methods to reduce the prevalence of SSI which may lead to improved prognosis.
Basic objectives2 Others
Basic objectives -Others The purpose of this study was to investigate risk factors of SSI in patients who underwent liver resection for CRLM and to establish methods to reduce the prevalence of SSI which may lead to improved prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of SSI
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
28 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Between May 2007 and March 2020, 151 consecutive patients with CRLM who underwent an initial liver resection.
Key exclusion criteria Staged hepatectomies.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Ikegami
Organization The Jikei University School of Medicine
Division name Division of Hepatobiliary and Pancreas Surgery, Department of Surgery
Zip code 105-8461
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Email toruikegamijikei@jikei.ac.jp

Public contact
Name of contact person
1st name Kenei
Middle name
Last name Furukawa
Organization The Jikei University School of Medicine
Division name Division of Hepatobiliary and Pancreas Surgery, Department of Surgery
Zip code 105-8461
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Homepage URL
Email k-furukawa@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Ethics Committee of the Jikei University School of Medicine
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan
Tel 03-3433-1111
Email rinri@jikei.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 151
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2020 Year 01 Month 01 Day
Date of IRB
2019 Year 08 Month 21 Day
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We investigated the relationship between the patient characteristics and perioperative factors and the incidence of SSI.

Management information
Registered date
2021 Year 06 Month 05 Day
Last modified on
2021 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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